Ankle Implant for Arthritis

Not currently recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Prisoner, Mentally incompetent, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Zimmer Trabecular Metal Total Ankle System, a special ankle implant, to evaluate its effectiveness for people with ankle arthritis. The goal is to assess the implant's durability and its impact on pain reduction and daily life improvement. It is open to individuals requiring first-time or replacement ankle surgery due to arthritis, whether from wear and tear, rheumatoid arthritis, or an old injury. As an unphased trial, this study provides a unique opportunity to contribute to advancements in ankle arthritis treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ankle implant is safe for arthritis patients?

Research has shown that the Zimmer Trabecular Metal Total Ankle System has undergone thorough testing for safety and effectiveness. A study in The Journal of Bone and Joint Surgery highlighted its excellent durability and long-term success for ankle replacement. Another study examined its safety in patients who received this ankle implant and found it was generally well-tolerated, with most patients experiencing good results.

While no treatment is without risk, the Zimmer Total Ankle System has demonstrated a strong safety record in past patients. There have been no major reports of serious unexpected complications linked to the implant, suggesting it is a safe option for those considering ankle replacement surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Zimmer Trabecular Metal Total Ankle System is unique because it uses a special type of porous metal that resembles bone structure, promoting better integration with the surrounding bone. This is a big leap forward from traditional ankle replacement options, which typically use solid metal components. Researchers are excited about this treatment as it potentially offers improved stability and longevity for patients with arthritis in the ankle, reducing the likelihood of loosening over time. Plus, it can be used for both primary and revision surgeries, making it a versatile option for those needing a replacement or an upgrade from earlier implants.

What evidence suggests that the Zimmer Trabecular Metal Total Ankle System is effective for arthritis?

Research shows that the Zimmer Trabecular Metal Total Ankle System, which participants in this trial will receive, effectively treats severe ankle arthritis. Studies have found that patients experience significantly less pain and improved movement over the long term. The implant is durable, ensuring longevity. Reports also highlight a special surgical method that contributes to the system's success. Overall, the Zimmer system is a dependable option for those needing ankle replacement surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Hillary Overholser, MS

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

This trial is for adults over 18 with arthritis (degenerative, rheumatoid, or post-traumatic) who need ankle replacement surgery. They must be able to consent and follow the study's procedures. Excluded are prisoners, those mentally unable to participate, non-compliant individuals, pregnant women, patients with infections or poor bone quality, and those with severe limb issues.

Inclusion Criteria

I am older than 18 years.

The patient is willing and able to provide written informed consent

My bones have stopped growing.

Exclusion Criteria

The patient has a known sensitivity or allergic reaction to one or more of the implanted materials

The patient is unwilling or unable to give consent or to comply with the follow-up program

I am not a prisoner, mentally competent, understand the study, and do not abuse substances.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Participants undergo preoperative clinical evaluations prior to their primary or revision total ankle arthroplasty

1-2 weeks

Treatment

Participants receive the Zimmer Trabecular Metal Total Ankle System during primary or revision total ankle arthroplasty

Surgical procedure

Post-operative Evaluation

Post-operative clinical and radiographic evaluations conducted at 6 weeks, 6 months, 1 year, 2, 3, 5, 7, and 10 years

10 years

Multiple visits over 10 years

Follow-up Surveys

Follow-up surveys conducted at 4, 6, 8, and 9 years to assess long-term outcomes

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Zimmer Trabecular Metal Total Ankle System

Trial Overview The Zimmer Trabecular Metal Total Ankle System is being tested in people needing ankle replacements due to arthritis. The study aims to track how well the implant works by looking at pain relief, improved function, life quality measures and checking x-rays for durability.

How Is the Trial Designed?

Group I: Zimmer TM Total Ankle System Experimental Treatment 1 Intervention

Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Citations

1. mdmercy.com mdmercy.com/about-mercy/news-and-media/news/2025/june/new-study-about-zimmer-total-ankle-replacement-using-unique-lateral-approach

New Study Shows Outstanding Long-Term Outcomes for ... New Study Shows Outstanding Long-Term Outcomes for Zimmer Total Ankle Replacement Using Unique Lateral Approach. June 10, 2025.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02038140

NCT02038140 | Zimmer Trabecular Metal Total Ankle PMCF The primary objective of this study is to obtain implant survivorship and clinical outcome data for commercially available Zimmer Trabecular Metal Total Ankle ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40299950/

Outcomes of Transfibular Total Ankle Arthroplasty Transfibular TAA is an effective and durable treatment option for end-stage ankle arthritis, with excellent mid-term implant survivorship.

4. prweb.com prweb.com/releases/new-study-shows-outstanding-long-term-outcomes-for-zimmer-total-ankle-replacement-using-unique-lateral-approach-302478205.html

New Study Shows Outstanding Long-Term Outcomes for ... The Zimmer Biomet lateral approach ankle replacement system offers a durable and effective solution for end-stage ankle arthritis.

5. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/specialties/foot-and-ankle/trabecular-metal-total-ankle.html

Trabecular Metal™ Total Ankle This innovative ankle replacement and instrument system bring the latest technological advances to total ankle arthroplasty. Lateral transfibular approach for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9489156/

Fixed-Bearing Trabecular Metal Total Ankle Arthroplasty ... This multicenter prospective cohort study assessed the safety and performance of the Trabecular Metal Total Ankle System (TM Ankle; Zimmer) for primary total ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10695343/

Two to Five-Year Outcomes of Total Ankle Arthroplasty with ... Our hypothesis was that the Infinity fixed-bearing TAA implant is a safe and effective implant for the treatment of end-stage ankle arthritis ...